Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding

Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02724150

Enrollment

Registered

2016-03-31

Start date

2017-12-01

Completion date

2021-07-31

Last updated

2018-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage

Keywords

Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage, Peptic Ulcer

Brief summary

Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding

Detailed description

Evaluate the efficacy of Two different regimens of proton pump inhibitors in the management of acute peptic ulcer bleeding First: loading dose 80 mg then 8mg/h iv continuous infusion for 3 days Second Loading dose 80 mg the 40 mg every 12 h for 3 days

Interventions

DRUGOmeprazole High dose

High regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days

DRUGOmeprazole Low dose

low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata, * active bleeding was defined as a continuous blood spurting (Forrest IA) * oozing (Forrest IB) from the ulcer base. * A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA). * An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).

Exclusion criteria

* ulcer was malignant * non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear....

Design outcomes

Primary

Measure	Time frame
Mortality	1 month

Secondary

Measure	Time frame	Description
Rebleeding	one month	recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment
Surgery	one month	need for surgery
Length of hospital stay	one month	—
Blood transfusions	one month	number of transfusion blood unites during admission

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026